Club Roots - 5% Minoxidil Topical Solution Hair Regrowth Treatment

Club Roots - 5% Minoxidil Topical Solution Hair Regrowth Treatment
SPL v2
SPL
SPL Set ID 925021bb-d1af-03b8-e053-2995a90a4243
Route
TOPICAL
Published
Effective Date 2019-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Water Isopropyl Alcohol Propylene Glycol

Identifiers & Packaging

Marketing Status
ANDA Active Since 2019-09-11

Description

Minoxidil 5% w/v


Medication Information

Warnings and Precautions

For external use only. For use by men only.

Flammable: Keep away from fire or flame

Description

Minoxidil 5% w/v

Use

Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

  • Chest pain, rapid heart beat, faintness, or dissiness occurs
  • Sudden, unexplained weight gain occurs
  • Your hands of feet swell
  • Scalp irritation or redness occurs
  • You get unwanted facial hair growth
  • You do not see hair regrowth in 4 months
Section 50567-7

When using this product

  • Do not apply on other parts of the body
  • Avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water
  • Some people have expereinced changes in hair color and/or texture
  • It takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results
  • The amount of hair regrowth is different for each person
  • This product will not work for all men
Section 50569-3

Ask your doctor before use if you have heart disease.

Section 50570-1

Do not use if:

  • You are a woman
  • Your amount of hair loss is different than shown on the side of this carton or hair loss is on the front of the scalp, 5% minoxidil topical solution is not intended for frontal baldness or receding hairline
  • You have no family history of hair loss
  • Your hair loss is sudden and/or patchy
  • You do not know the reason for your hair loss
  • You are under 18 years of age. Do not use on babies or children
  • Your scalp is red, inflamed, infected, irritated, or painful
  • You use other medicines on the scalp
Section 51727-6

Alcohol, Propylene Glycol, Purified Water

Section 51945-4

Section 53414-9

May be harmful if used when pregnant or breast-feeding.

Section 55105-1

Hair regrowth treatment for men

Section 55106-9

Minoxidil 5% w/v

Section 60561-8
  • See hair loss pictures on the side of this carton
  • Before use, read all information on carton and enclosed leaflet
  • Keep the carton. It contains important information
  • Hair regrowth has not been shown to last longer than 48 weeks in large clinical trialse with continuous treatment with 5% minoxidil topical solution for men
  • In clincial studies of mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provide more hair regrowth than 2% minoxidil topical solution
  • Store at controlled room temperature 20 o to 25 oC (68 o to 77 o F)
Directions

  • apply 1mL with sprayer (6 sprays) 2 times a day directly onto the scalp in the hair loss area
  • using more or more often will not improve results
  • continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

Structured Label Content

Use (USE)

Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

Warnings and Precautions (34071-1)

For external use only. For use by men only.

Flammable: Keep away from fire or flame

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • Chest pain, rapid heart beat, faintness, or dissiness occurs
  • Sudden, unexplained weight gain occurs
  • Your hands of feet swell
  • Scalp irritation or redness occurs
  • You get unwanted facial hair growth
  • You do not see hair regrowth in 4 months
Section 50567-7 (50567-7)

When using this product

  • Do not apply on other parts of the body
  • Avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water
  • Some people have expereinced changes in hair color and/or texture
  • It takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results
  • The amount of hair regrowth is different for each person
  • This product will not work for all men
Section 50569-3 (50569-3)

Ask your doctor before use if you have heart disease.

Section 50570-1 (50570-1)

Do not use if:

  • You are a woman
  • Your amount of hair loss is different than shown on the side of this carton or hair loss is on the front of the scalp, 5% minoxidil topical solution is not intended for frontal baldness or receding hairline
  • You have no family history of hair loss
  • Your hair loss is sudden and/or patchy
  • You do not know the reason for your hair loss
  • You are under 18 years of age. Do not use on babies or children
  • Your scalp is red, inflamed, infected, irritated, or painful
  • You use other medicines on the scalp
Section 51727-6 (51727-6)

Alcohol, Propylene Glycol, Purified Water

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

May be harmful if used when pregnant or breast-feeding.

Section 55105-1 (55105-1)

Hair regrowth treatment for men

Section 55106-9 (55106-9)

Minoxidil 5% w/v

Section 60561-8 (60561-8)
  • See hair loss pictures on the side of this carton
  • Before use, read all information on carton and enclosed leaflet
  • Keep the carton. It contains important information
  • Hair regrowth has not been shown to last longer than 48 weeks in large clinical trialse with continuous treatment with 5% minoxidil topical solution for men
  • In clincial studies of mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provide more hair regrowth than 2% minoxidil topical solution
  • Store at controlled room temperature 20 o to 25 oC (68 o to 77 o F)
Directions (DIRECTIONS)

  • apply 1mL with sprayer (6 sprays) 2 times a day directly onto the scalp in the hair loss area
  • using more or more often will not improve results
  • continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

Advanced Ingredient Data


Raw Label Data

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